Prospect: Information for the user

Cilostazol Tarbis 100 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4

1.What is Cilostazol Tarbis and how is it used

2.What you need to know before starting to take Cilostazol Tarbis

3.How to take Cilostazol Tarbis

4.Possible adverse effects

5.Storage of Cilostazol Tarbis

6.Contents of the package and additional information

Cilostazol Tarbis belongs to a group of medications known as type 3 phosphodiesterase inhibitors.

It has various actions, including the dilation of certain blood vessels and the reduction of the coagulant activity (agglutination) of certain blood cells, called platelets, in blood vessels.

Cilostazol Tarbis has been prescribed for «intermittent claudication». Intermittent claudication is the cramping pain that you experience in your legs when walking and is caused by an insufficient blood supply to the legs. Cilostazol Tarbis may help you increase the walking distance, as it improves blood circulation in the legs. Cilostazol is only recommended for patients whose symptoms have not improved enough after making lifestyle changes (such as quitting smoking and exercising more) and after other appropriate interventions. It is essential that you continue with the lifestyle changes you have made while taking cilostazol.

Do not take Cilostazol Tarbis

• if you are allergic to cilostazol or any of the other components of this medication, (including those listed in section 6).
• if you have a known condition called "heart failure",
• if you suffer from persistent chest pain at rest, or have had a "heart attack" or any heart surgery in the last six months,
• if you suffer or have previously suffered from fainting due to heart disease or severe heart rhythm disorders,
• if you know you suffer from any condition that increases the risk of bleeding or bruising, for example:

• active ulcers in the stomach
• stroke (cerebral hemorrhage) in the last six months
• eye problems if you suffer from diabetes
• uncontrolled high blood pressure
• if you are taking aspirin and clopidogrel, or any combination of two or more medications that may increase your risk of bleeding [consult your doctor or pharmacist if you are unsure]

• severe kidney disease or moderate to severe liver disease,
• if you are pregnant.

Warnings and precautions

Before taking Cilostazol Tarbis, make sure your doctor knows:

• if you suffer from any severe heart condition or any other heart rhythm disorder;
• if you suffer from any blood pressure disorder.

• during treatment with Cilostazol Tarbis ensure that
• in the event that you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking Cilostazol Tarbis.
• if you suffer from bruising or bleeding easily, stop taking Cilostazol Tarbis and inform your doctor.

Taking Cilostazol Tarbis with other medications

Before starting to take Cilostazol Tarbis, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

You must inform your doctor specifically if you take medications that are commonly used to treat painful and/or inflammatory conditions in the muscles or joints, as well as if you take medications to reduce blood clotting. Among these medications are:

• aspirin
• clopidogrel
• anticoagulant medications (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

In the event that you are taking these medications with Cilostazol Tarbis, your doctor may need to perform routine blood tests.

Certain medications may interfere with the effect of Cilostazol Tarbis when taken together. They may increase the adverse effects of Cilostazol Tarbis or reduce its efficacy. Cilostazol Tarbis may have the same effects on other medications. Before starting to take Cilostazol Tarbis, inform your doctor or pharmacist if you are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics)
• ketoconazole (to treat fungal infections)
• omeprazole (to treat excessive acid in the stomach)
• diltiazem (to treat high blood pressure or chest pain)
• cisapride (to treat some stomach disorders)
• lovastatin, simvastatin, or atorvastatin (to treat high cholesterol in the blood)
• halofantrine (to treat malaria)
• pimozide (to treat mental disorders)
• ergot derivatives (to treat migraines, e.g., ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (to treat seizures)
• St. John's Wort or hypericum (herbal remedy)

If you are unsure whether this applies to the medications you are taking, consult your doctor or pharmacist.

Before starting to take Cilostazol Tarbis, inform your doctor or pharmacist about any medications you are taking to treat high blood pressure, as Cilostazol Tarbis may have an additional effect of lowering blood pressure. In the event that your blood pressure decreases excessively, you may experience an acceleration of heart rate. Among these medications are:

• diuretics (e.g., hydrochlorothiazide, furosemide)
• calcium channel blockers (e.g., verapamil, amlodipine)
• ACE inhibitors (e.g., captopril, lisinopril)
• angiotensin II receptor antagonists (e.g., valsartan, candesartan)
• beta-blockers (e.g., labetalol, carvedilol)

You may be able to take the aforementioned medications together with Cilostazol Tarbis. Your doctor will decide whether this is suitable in your case.

Use of Cilostazol Tarbis with food, drinks, and alcohol

You should take the Cilostazol Tarbis tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKECilostazol Tarbis during pregnancy.

DO NOT RECOMMENDtaking Cilostazol Tarbis during breastfeeding.

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Cilostazol Tarbis may cause dizziness. If you feel dizzy after taking Cilostazol Tarbis, DO NOT DRIVE or operate any tools or machinery and inform your doctor or pharmacist.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended doseis a 100 mg tablet taken twice a day (in the morning and in the evening). It is not necessary to adjust this dose for elderly patients. However, your doctor may need to prescribe a lower dose if you are taking other medications that could interfere with the effect of cilostazol.

You must take the Cilostazol Tarbis tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may notice the benefits of taking Cilostazol Tarbis at 4-12 weeks of treatment. At 3 months of treatment, your doctor will evaluate your progress and may recommend that you stop taking cilostazol if the treatment effect is not sufficient.

Use in children and adolescents

Cilostazol Tarbis is not suitable for children.

If you take more Cilostazol Tarbis than you should

If you take more tablets of Cilostazol Tarbis than you should for any reason, you may experience symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeats.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Cilostazol Tarbis

Do not worry if you forget to take a dose. Wait until the next dose and continue taking the treatment normally.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Cilostazol Tarbis

If you interrupt treatment with Cilostazol Tarbis, the pain in your legs may return or worsen. Therefore, you should only stop taking Cilostazol Tarbis if you detect emergency medical attention required side effects (see section 4) or if your doctor advises you to do so.

Like all medications, Cilostazol Tarbis may produce side effects, although not everyone will experience them.produceside effects, although not everyone will experience them.

If any of the following side effects occur, you may need urgent medical attention. Stop taking Cilostazol Tarbis and contact your doctor or go immediately to the nearest hospital.

• stroke (apoplejía)
• heart attack (infarto de miocardio)
• heart problems, which may cause difficulty breathing or swelling of the ankles
• irregular heartbeat (new or worsening)
• notable bleeding
• easily bruising
• serious skin condition with blistering, mouth, eyes, or genital area
• yellowing of the skin or white of the eyes due to liver or blood problems (jaundice)

You should also inform your doctor immediately if you have a fever or sore throat. Blood tests may be required; your doctor will decide on the treatment to be administered.

The following side effects have been observed in patients treated with Cilostazol Tarbis. If you experience them, you should inform your doctor immediately:

Very common side effects(may affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhea

Common side effects(may affect up to 1 in 10 people)

• rapid heartbeat
• palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• indigestion
• nausea or vomiting
• loss of appetite (anorexia)
• excessive gas or flatulence
• inflammation of the ankles, feet, or face
• skin rash or changes in skin appearance
• itching skin
• hemorrhagic patches on the skin
• general weakness

Rare side effects(may affect up to 1 in 1,000 people)

• prolonged bleeding
• increased platelet count in the blood
• kidney problems

The following side effects have been observed during the use of Cilostazol Tarbis, but the frequency with which they occur is unknown:

• changes in blood pressure
• decrease in red blood cell, white blood cell, and platelet count in the blood
• difficulty breathing
• difficulty walking
• fever
• seizures
• eczema and other skin eruptions
• numbness in the skin
• tearful or sticky eyes (conjunctivitis)
• tinnitus (ringing in the ears)
• liver problems, including hepatitis
• changes in urine

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of Cilostazol Tarbis

• The active ingredient is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other components are cornstarch, microcrystalline cellulose, calcium carmelose,

hypromellose and magnesium stearate.

Appearance of the product and content of the packaging

Cilostazol Tarbis 100 mg is a white, round, and scored tablet on one side. The medication is supplied in packaging of 56 tablets or in hospital packaging with 70 (5x14) tablets.

Holder of the marketing authorization

TARBIS FARMA, S.L.

Gran Via Carlos III, 94

08028 Barcelona, Spain

Responsible for manufacturing

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

(Barcelona – Spain)

Date of the last review of this leaflet:November 2013

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/